A randomized control trial to study the antibody response and side effects after the booster dose of COVID-19 vaccine
Phase 3
- Registration Number
- CTRI/2022/01/039677
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy volunteers above 18 years who have received 2 doses of ChAdOx1 nCoV-19 vaccine
Able and willing to comply with study requirements
Willing to refrain from blood donation during the study period
giving consent
Exclusion Criteria
Anaphylactic reaction following administration of vaccine previously
Pregnant or lactating women
Any adverse event that in the opinion of the Investigator may affect the safety of the participant or the interpretation of the study results
Subject not giving consent
Individuals who have received any other COVID1-9 vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess efficacy and immunogenicity of the booster dose of ChAdOx1 nCoV-19 (COVISHIELD) against COVID-19 in vaccine recipients compared to the placebo groupTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method Assess the safety of the booster dose of ChAdOx1 nCoV (COVISHIELD: Occurrence of serious adverse events (SAEs)Timepoint: Upto 6 months